I. Field of the Invention
The present invention relates to medical devices and methods generally aimed at surgical implants. In particular, the disclosed system and associated methods are related to a manner of creating surgical implants via embroidery.
II. Discussion of the Prior Art
Embroidered structures are created on substrates. Some substrates are designed to stay in place with the embroidered structure while other substrates are removed at the end of the embroidery process. If the substrate is designed to be removed, the preferred method of removal is dissolution. The dissolution processes discussed, however, are not intended to preclude the use of other means of substrate removal which those skilled in the art would employ in the manufacture of an embroidered structure, or the omission of substrate removal.
As an initial step in the creation of embroidered structures, a plurality of parallel, stationary backing threads are placed and secured on one surface of a substrate, called the “backing surface.” On the opposing surface of the substrate, called the “stitching surface,” is a plurality of stitching threads with one-to-one correspondence to the backing threads. Stitching may be done between one pair of threads at a time or in simultaneous multiplicity, as is described below.
The plurality of stitching threads from the stitching surface are passed to the backing surface through openings created in the substrate by the passing of each individual thread. Each stitching thread is then looped over its corresponding backing thread, in essence picking up the backing thread, which creates a lock stitch. Once each stitching thread has picked up its corresponding backing thread, the plurality of stitching threads are returned to the stitching surface by passing through the openings in the substrate created by initially passing the stitching threads to the backing surface. The lock stitches prevent the stitching threads from completely pulling back out of the openings created in the substrate. The plurality of stitching threads are then moved to a new stitching site and the process repeats until all the backing threads are joined by lock stitches to the corresponding stitching threads, creating a plurality of thread pairs of some length.
A plurality of thread pairs may be enclosed by one or more pluralities of enclosing thread pairs. To enclose a plurality of thread pairs, a subsequent plurality of backing threads are placed and secured on the backing surface of a substrate already holding at least one plurality of thread pairs, such that the subsequent plurality of backing threads covers the previously stitched plurality of backing threads. A subsequent plurality of backing threads is usually not parallel with the previous plurality of backing and stitching threads. A subsequent plurality of stitching threads, with one-to-one correspondence to the subsequent plurality of backing threads, is then stitched to the subsequent plurality of backing threads by the stitching process described above.
When the subsequent plurality of backing threads are all joined to the subsequent plurality of stitching threads by lock stitches over a desired distance, a plurality of enclosing thread pairs has been formed, enclosing all previously stitched pairs. This process may be repeated by stitching even further subsequent pluralities of enclosing thread pairs over the previously stitched thread pairs and enclosing thread pairs, such that, for example, the first plurality is enclosed by a second plurality, which is enclosed by a third plurality, which is enclosed by a fourth plurality, and so forth. This process produces stable embroidered structures which do not unravel into a pile of threads if the substrate is removed.
If the substrate is intended to be removed, the removal process is dependent upon the material from which the substrate is composed. If dissolution is the removal method chosen, the substrate materials are chosen such that the process which dissolves the substrate will minimally affect the physical properties of the stitching or backing threads used in the embroidered structure. When the substrate is removed, only the stitching and backing threads remain, in whatever combination of thread pairs and enclosing thread pairs that were utilized. The embroidered structure remains intact despite the removal of the substrate because each stitching thread is stitched to its corresponding backing thread, and vice versa, which is enclosed in one or more pluralities of enclosing thread pairs, all of which provides structural support.
In some applications, it may be advantageous to have an independent, unpaired thread, referred to as a “lace,” existing within an embroidered structure. Based upon the methodology of embroidered structure creation above, however, any lace within an embroidered structure would have to be placed after completion of the embroidery process because all threads are stitched, and thus paired, during the embroidery process. On a basic level, one or more laces may be added to an embroidered structure by hand, but this is possible only with the simplest of embroidered structures. The manual placement of laces is also expensive, not easily repeatable, and not conducive to mass production.
Repeatability is paramount in medical applications because devices may work reliably in one configuration, but variations of such a configuration may cause the device to perform unreliably, inadequately, or even fail to perform altogether. Repeatable placement of a lace within an embroidered structure used for surgical implantation requires a level of reproducibility exceeding that which may be achieved manually. Repeatability notwithstanding, the expense required to manually add one or more laces to embroidered structures further limits the use of manual insertion techniques, as does the bottleneck such manual insertions would cause in a manufacturing environment.
The present invention overcomes, or at least minimizes, the limitations associated with placing one or more laces within an embroidered structure.
According to the present invention, there is provided a manufacturing process by which an embroidered structure may be created containing within the structure one or more independent, unpaired threads laces, in a manner which is repeatable, inexpensive, and conducive to mass production.
The advantages to placing laces using the process of the present invention are: (1) ease of manufacture of complex devices; (2) the ability to make more complex devices; (3) the ability to improve the repeatability of strength critical items; (4) the ability to pre-load seams; and (5) the ability to create three-dimensional shapes.
The process of the present invention may use any of a variety of commercially available, automated embroidery machines and/or any other non-manual technique used to manufacture embroidered structures. A soluble thread composed of acetate (for example) or other soluble material is used as the corresponding partner thread for the lace thread during the embroidery process. The lace thread is stitched with the soluble thread, forming in the embroidered structure a temporary thread pair in the same creation process in which all the other threads in the embroidered structure are stitched. The soluble thread may be either the stitching thread or backing thread, and thus the lace may be placed into the embroidered structure as either the stitching or backing thread.
After the stitching of the embroidered structure is complete, the soluble thread is dissolved. The dissolution process used must be suitable for dissolving the material of the soluble thread and should preferably not negatively alter the physical properties of the lace and other threads in the embroidered structure. Once the soluble thread is removed, the temporary thread pair formed by the soluble thread being stitched with the lace ceases to exist, and the lace is no longer a part of the support system of the embroidered structure. This leaves the lace as a single, unpaired thread within the embroidered structure of paired threads.
Removal of the substrate may be done before, during and/or after the dissolution of the soluble thread, depending upon the properties of the materials used for the substrate and soluble thread and any specific manufacturing concerns compelling the sequence of removal. If dissolution is the method of removal selected, the dissolution processes for the substrate will not only depend upon the substrate material, but also the material of the soluble threads, laces and other threads in the embroidered structure to ensure that the process only affects the materials targeted by the process.
Since the lace was a part of the embroidered structure as it was being created and not placed from outside the otherwise finished embroidered structure, and because the creation was performed non-manually, the positional repeatability of the lace within the embroidered structure is high. The replacement of standard threads with soluble threads and the addition of a process to remove the soluble thread, if not removed during a substrate dissolution process, only nominally increases the cost of manufacturing with laces as opposed to without, and the cost increase is significantly less that of the cost of placing laces by hand. Finally, since the method of creation may be automated using commercially available embroidery machines, the embroidered structures containing laces may be mass produced. Thus, the present invention overcomes, or at a minimum improves upon, the limitations associated with repeatability, expense, and mass producibility inherent to the prior art.
Many advantages of the present invention will be apparent to those skilled in the art with a reading of this specification in conjunction with the attached drawings, wherein like reference numerals are applied to like elements and wherein:
Illustrative embodiments of the invention are described below. In the interest of clarity, not all features of an actual implementation are described in this specification. It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure. The process of embroidery with soluble thread disclosed herein boasts a variety of inventive features and components that warrant patent protection, both individually and in combination.
Stitching may be done between one pair of threads at a time or in simultaneous multiplicity, as is described below. The plurality of stitching threads, lace threads, and/or soluble threads on the stitching surface are passed from the stitching surface to the backing surface, making openings in the substrate for each individual thread, to meet with corresponding backing threads, soluble threads, and/or laces on the backing surface. Each stitching thread, lace, and/or soluble thread from the stitching surface is then looped over its corresponding backing thread, soluble thread, and/or laces on the backing surface. In essence, this looping over engages or “picks up” each thread from the backing surface, creating a “lock stitch.” Once each thread from the stitching surface has picked up its corresponding thread from the backing surface, the plurality of threads originating from the stitching surface are returned from the backing surface to the stitching surface through the same openings made upon initial passage through the substrate from the stitching surface. The lock stitch prevents the threads from completely pulling out of the openings made when returning to the stitching surface through the substrate.
The process then repeats at a distance from the last stitch site, and continues to repeat until each thread from the stitching surface and its corresponding thread from the backing surface are joined by lock stitches over a desired length. The end result is a plurality of stitching threads stitched to backing threads in thread pairs held together by lock stitches. Each thread pair is parallel to the rest of the thread pairs on the substrate. Also parallel to the thread pairs are the one or more temporary thread pairs formed by stitching laces to corresponding soluble threads.
A plurality of parallel stitched thread pairs and temporary thread pairs may be enclosed by enclosing thread pairs. To enclose a previously stitched plurality of thread pairs and temporary thread pairs, the embroidery process above is repeated over the previous embroidery already on the substrate. This process may be repeated further by embroidering subsequent pluralities of enclosing thread pairs over each other in a manner such that the first plurality of enclosing thread pairs is enclosed by the second plurality of enclosing thread pairs, which is enclosed by a third plurality, which is enclosed by a fourth plurality, and so forth. This process of producing embroidered structures containing multiple pluralities of enclosing thread pairs results in stable embroidered structures which do not unravel into a pile of threads upon removal of the substrate.
The process of substrate removal, if not omitted, is dependent upon the material from which the substrate is composed. Removal of the substrate may be done before, after or simultaneously with the dissolution of the soluble thread(s). If dissolution is the chosen method or removal, the selection of materials used to form the substrate and soluble thread will be in part compelled by any manufacturing concerns regarding the sequence of dissolution. Substrate and soluble thread materials are chosen such that the process or processes which dissolve the substrate and soluble thread will not negatively alter the physical properties of the stitching threads, backing threads, and/or laces.
If the substrate is removed and the soluble threads are dissolved, only the stitching threads, backing threads, and/or laces will remain. The embroidered structure remains intact despite the removal of the substrate because each stitching thread is stitched to its corresponding backing thread, and vice versa, which is enclosed in one or more pluralities of enclosing thread pairs, all of which provides structural support. Once both the soluble threads and substrate are removed, the laces are no longer a part of the support system of the embroidered structure because the temporary thread pairs cease to exist when the soluble threads are dissolved, leaving the laces as single, unpaired threads within the embroidered structure.
The embroidered structure 10 is shown by way of example enclosed by a first plurality of enclosing thread pairs 22. The same stitching process or a different stitching process may be repeated or performed one or more times using the same or different thread materials to enclose thread pairs 20 and temporary thread pairs 30 by multiple pluralities of enclosing thread pairs 22 such that each subsequent plurality of enclosing thread pairs encloses all thread pairs 20, temporary thread pairs 30 and previous enclosing thread pairs 22 over which it is embroidered.
As shown in
As shown in
The woven structure 26 is exemplary of the use of the embroidering techniques of the present invention to create non-embroidered finished products. The extent of these non-embroidered products is not limited to those which are woven, but includes all other methods of creating structures from filamentary materials. The finished products may be completely non-embroidered or a hybrid of embroidery and one or more other techniques including, but not limited to, weaving.
Woven structures may also take many shapes. For example, the woven structure 26 from
This order and position creates a honeycomb-shaped woven structure 26. However, different weaving effects give structures different properties, including but not limited to flexibility and feel.
After dissolution of the soluble thread and substrate, this order and position creates a diagonal weave throughout the woven structure 26. This weave will have different characteristics, including but not limited to flexibility and feel, than that of the woven structure 26 in
As evidenced above, the present invention overcomes, or at least minimizes, the drawbacks of the prior art. The devices described herein may be repeatably mass produced based on the automated nature of the embroidery process of the present invention. Embroidery with one soluble thread allows for a single, unpaired lace to be laid down reliably, cost effectively, and in a manner conducive to mass production.
While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined herein.
The present international patent application claims the benefit of priority from commonly owned and co-pending U.S. Provisional Patent Application Ser. No. 60/847,022, entitled “Embroidery Using Soluble Thread,” filed on Sep. 25, 2006, the entire contents of which are hereby expressly incorporated by reference into this disclosure as if set forth fully herein.
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